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ARTICLE | Clinical News

Abivax's ABX464 improves mucosal healing, Mayo Score in Phase IIa for UC

September 7, 2018 6:14 PM UTC

Abivax S.A. (Euronext:ABVX) said ABX464 improved mucosal healing rate (50% vs. 11%, p=0.03) and reduced partial (62% vs. 32%, p<0.02) and total Mayo Scores (53% vs. 37%, p<0.03) at eight weeks vs. placebo in 29 evaluable patients in the Phase IIa ABX464-101 trial to treat moderate to severe ulcerative colitis. The company expects to present final data by October and to submit a clinical trial application for a Phase IIb trial by next quarter.

The double-blind, European trial enrolled 32 patients who failed immunomodulators, anti-TNFα, Entyvio vedolizumab and/or corticosteroids to receive once-daily 50 mg oral ABX464 for two months. At week eight, ABX464 led to a clinical remission rate of 35% and a clinical response rate of 70% vs. 11% and 33%, respectively for placebo. Remission was defined as a total Mayo Score of 2 points or less with no subscore greater than 1 point. The trial’s primary endpoint was safety...

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